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Change titleChange detailChange dateDatasheetCreated by
Itrafungol 10 mg/ml Oral SolutionChange(s) in the Summary of Product Characteristics, Labelling or Package Leaflet to implement the outcome of the MAH’s signal management process.22 December 2024Itrafungol 10 mg/ml Oral Solutionvirbac-mottram
Itrafungol 10 mg/ml Oral SolutionAddition of adverse event wording "sometimes fatal" in relation to a very rare transient increase in liver enzymes, "In very rare cases elevated total bilirubin may occur" and "In very rare cases weight loss may occur." Addition of "commonly" in relation to events "Salivation, vomiting, diarrhoea, anorexia, depression and apathy" on product leaflet.26 November 2024Itrafungol 10 mg/ml Oral Solutionvirbac-mottram
Itrafungol 10 mg/ml Oral SolutionOne-off alignment of the product information with version 3 of the QRD templates.16 May 2026Itrafungol 10 mg/ml Oral Solutionvirbac-mottram
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